meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
55
Latest Decision
2008-09-26

Clearances · page 70 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K081808 ACUNAV V ULTRASOUND CATHETER Siemens Medical Solutions USA, Inc. OBJ Class II 2008-09-26
K080602 AUDICOR SENSOR, MODELS: 2.0, 3.0 Inovise Medical, Inc. DRX Class II 2008-09-25
K081442 HEART SYNC PEDIATRIC, MODEL PED-100 Heart Sync, LLC LDD Class II 2008-09-24
K081371 SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL Leonhard Lang GmbH MKJ Class III 2008-09-24
K081800 T12S TELEMETRY TRANSMITTER Mortara Instrument, Inc. DQA Class II 2008-09-24
K082736 RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER Terumo Medical Corp. DQO Class II 2008-09-24
K081574 ZOLL R SERIES ZOLL Medical Corporation LDD Class II 2008-09-18
K082425 TANDEMHEART TRANSSEPTAL CANNULA- EF 72 Cardiacassist, Inc. DWF Class II 2008-09-18
K082644 GLIDESHEATH Terumo Medical Corp. DYB Class II 2008-09-18
K082542 ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A Cardicare Company, Ltd. DXQ Class II 2008-09-17
K082023 REPROCESSED ELECTROPHYSIOLOGY CATHETERS Ascent Healthcare Solutions NLH Class II 2008-09-16
K081394 PTFE INTERLOCK PEELABLE INTRODUCERS Enpath Medical, Inc. DYB Class II 2008-09-15
K082312 PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM) Heartscape Technologies, Ltd. DPS Class II 2008-09-12
K080470 ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32 Maquet Cardiopulmonary, AG KFM Class II 2008-09-12
K081712 FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700 Guangdong Biolight Meditech Co., Ltd. DQA Class II 2008-09-12
K081523 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM Abbott Vascular-Vascular Solutions NTE Class II 2008-09-11
K082467 ENSITE FUSION DYNAMIC REGISTRATION TOOL St Jude Medical DQK Class II 2008-09-11
K082343 VASCUTRAK 2, MODELS: V14 AND V18 Ymed, Inc. PNO Class II 2008-09-11
K080592 HLM TUBING SET WITH BIOLINE COATING Maquet Cardiopulmonary, AG DWE Class II 2008-09-11
K081659 RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L Masimo Corporation DQA Class II 2008-09-09
K073545 AUDICOR, HEMO AMBULATORY MONITOR Inovise Medical, Inc. MWJ Class II 2008-09-09
K080116 TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM Transonic Systems, Inc. DXG Class II 2008-09-08
K070488 MICARDIA ANNULOPLASTY BAND DR Micardia Corporation KRH Class II 2008-09-04
K082077 BT3/6, BT12 Corscience GmbH & Co. KG DXH Class II 2008-09-02
K081937 PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE OXIMETRY MODULE Philips Medizin Systeme Boeblingen GmbH DQA Class II 2008-08-29
K081891 FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR Fukuda Denshi USA, Inc. MHX Class II 2008-08-29
K082186 MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM Pathway Medical Technologies, Inc. MCW Class II 2008-08-29
K082356 GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE W. L. Gore & Associates, Inc. DYB Class II 2008-08-28
K082304 ROLL-X GUIDEWIRE St Jude Medical DQX Class II 2008-08-27
K080861 MICRUS ASCENT OCCLUSION BALLOON CATHETER Micrus Endovascular Corporation MJN Class II 2008-08-27
K081762 CURBELL PATIENT MONITORING CABLES Curbell Electronics, Inc. DSA Class II 2008-08-27
DEN080007 ALLOMAP MOLECULAR EXPRESSION TESTING Xdx OJQ Class II 2008-08-26
K082173 Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S Cardiac Science Corporation DPS Class II 2008-08-26
K082143 MICRO GUIDE CATHETER XP Cordis Corp. PDU Class II 2008-08-25
K081983 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00 Philips Medical Systems MHX Class II 2008-08-22
K073334 OHMNISCAN NG Christine Valmy, Inc. MNW Class II 2008-08-22
K072950 CYGNUS 12 LEAD ECG MODULE Cygnus, LLC KRE Class II 2008-08-22
K082061 INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER Irvine Biomedical, Inc. DRF Class II 2008-08-19
K081465 AXIUM DETACHABLE COIL SYSTEM Micro Therapeutics, Inc. KRD Class II 2008-08-19
K082191 CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 Cardiomems, Inc. NQH Class II 2008-08-19
K081549 RX ACCUNET LP EMBOLIC PROTECTION SYSTEM Abbott Laboratories NTE Class II 2008-08-19
K081365 SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR St Jude Medical MXC Class II 2008-08-15
K082034 MODIFICATION TO MERCI RETRIEVER Concentric Medical, Inc. NRY Class II 2008-08-15
K081951 ANEROID SPHYGMOMANOMETER, MODEL KT-A01 Wenzhou Kindcare Import & Export Co., Ltd. DXQ Class II 2008-08-15
K080189 TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX Trimline Medical Products Corp. DXQ Class II 2008-08-15
K082075 HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER Hansen Medical, Inc. DRE Class II 2008-08-15
K081944 MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM Cardio Systems, Inc. MCW Class II 2008-08-14
K081936 SOLEX CATHETER, MODEL SL2593 Alsius Corp. NCX Class II 2008-08-13
K080637 POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS Stereotaxis, Inc. DQX Class II 2008-08-12
K080364 FINDRWIRZ GUIDE WIRE SYSTEM Sentreheart, Inc. DQX Class II 2008-08-11
K082059 ANGIOSCULPT PTA SCORING BALLOON CATHETER Angioscore, Inc. PNO Class II 2008-08-11
K081021 KINETIX GUIDEWIRE, PLUS GUIDEWIRE Boston Scientific Corp DQX Class II 2008-08-08
K080737 MIRAFLEX HIGH FLOW MICROCATHETER Cook, Inc. KRA Class II 2008-08-08
K081337 APPROACH CTO WIRE GUIDE Cook Incorporated DQX Class II 2008-08-08
K081159 HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES Harvard Medical Devices , Ltd. DXN Class II 2008-08-08
K080899 ARCTIC BLAST INTRAVENOUS FLUID CHILLER Medivance, Inc. NCX Class II 2008-08-07
K081804 PIONEER PLUS CATHETER Medtronic, Inc. PDU Class II 2008-08-05
K073523 INTERCEPTOR PLUS CORONARY FILTER SYSTEMS Medtronic, Inc. NFA Class II 2008-08-01
K082045 MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 Spacelabs Medical, Inc. MHX Class II 2008-08-01
K080326 KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR Andon Health Co, Ltd. DXN Class II 2008-07-31
K081870 MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO GE Healthcare Finland Oy DQA Class II 2008-07-31
K072109 STATMAP, MODEL 7200 Ramsey Medical, Inc. DXN Class II 2008-07-31
K081552 SKYLINE 55 Larsen & Toubro Limited MWI Class II 2008-07-31
K081444 BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM Braemar, Inc. DSI Class II 2008-07-31
K080832 STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER Sorin Group Deutschland GmbH DTQ Class II 2008-07-30
K080668 G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS C.R. Bard, Inc. DTK Class II 2008-07-30
K073089 LIFEPAK 20E Physio-Control, Inc. MKJ Class III 2008-07-29
K081238 REPROCESSED MASIMO PULSE OXIMETER SENSORS Ascent Healthcare Solutions NLF Class II 2008-07-29
K081233 T-STAT 303 ISCHEMIA MONITORING SYSTEM Spectros Corporation MUD Class II 2008-07-28
K080178 VALVULOTOME BY KOVEN Koven Technology, Inc. MGZ Class II 2008-07-28
K080849 MICROSHEATH LP AND LP-AT Flowcardia, Inc. DQY Class II 2008-07-25
K073249 SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES Solaris Medical Technology, Inc. DQA Class II 2008-07-25
K081776 CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM Omega Critical Care Limited DXG Class II 2008-07-22
K080583 MODIFIED HD GUIDE CATHETER Concentric Medical, Inc. DQY Class II 2008-07-18
K081328 PATHWAY PV ATHERECTOMY SYSTEM Pathway Medical Technologies, Inc. MCW Class II 2008-07-17
K081140 VISENSIA Obs Medical MHX Class II 2008-07-17
K081437 MAC 1600 ECG ANALYSIS SYSTEM Ge Medical Systems Information Technologies DPS Class II 2008-07-15
K080982 STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS Boston Scientific Corp LIT Class II 2008-07-14
K080047 CARDIOSEN'C Shl Telemedicine International , Ltd. DXH Class II 2008-07-11
K081680 NUCLEUS-X, MODEL 230X NuMED, Inc. DQY Class II 2008-07-10
K081329 REPROCESSED ELECTROPHYSIOLOGY CATHETERS Ascent Healthcare Solutions NLH Class II 2008-07-09
K053310 VASCON ROAMER MICROCATHETER Vascon, LLC KRA Class II 2008-07-03
K080319 KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR Andon Health Co, Ltd. DXN Class II 2008-07-02
K081125 WRIST PULSE OXIMETER MD300W Beijing Choice Electronic Technololgy Co., Ltd. DQA Class II 2008-07-02
K080813 PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER Radi Medical Systems AB DXO Class II 2008-07-01
K073225 SENSEI CATHETER CONTROL SYSTEM Hansen Medical, Inc. DXX Class II 2008-06-30
K081473 HERO, VERSION 2.0 Medical Predictive Science Corp. DPS Class II 2008-06-27
K080798 INTEL HEALTH GUIDE, MODEL: PHS6000 Intel Corp. DRG Class II 2008-06-27
K073631 ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100 Orqis Medical Corporation KFM Class II 2008-06-27
K081049 FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 Cryocath Technologies, Inc. DRA Class II 2008-06-27
K081573 MEDTRONIC EXPORT AP CATHETER Medtronic Vascular DXE Class II 2008-06-27
K081467 EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION Ekos Corp. QEY Class II 2008-06-26
K081471 ECARD AND CCARD iRhythm Technologies, Inc. DXH Class II 2008-06-24
K073280 BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. MHX Class II 2008-06-23
K081484 HORIZON XVU Mennen Medical , Ltd. DQK Class II 2008-06-20
K080251 APEXPRO TELEMETRY SYSTEMS Ge Medical Systems Information Technologies MHX Class II 2008-06-20
K080765 CROSSER LP SYSTEM Flowcardia, Inc. DQX Class II 2008-06-20
K080112 PATIENT CABLE Med-Dyne DSA Class II 2008-06-20
K081590 YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J Ya Horng Electronic Co., Ltd. DXN Class II 2008-06-19
K081221 LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE Levitronix, LLC DWA Class II 2008-06-19

19,212 clearances in the Cardiovascular panel. Data: openFDA.